FDA Challenges Stem Cell Companies As Patients Run Out Of Time

Scientists have seen promise in the potential of stem cells, but not everyone agrees stem cell replacement therapy is ready for prime time.

Americans seeking stem cell replacement therapy hope the process can heal them of myriad diseases, and a 2011 report by the Baker Institute estimated the industry could bring in $16 billion in revenue by 2020.

But the Food and Drug Administration has expressed concerns. The agency sued to stop treatments at a Regenerative Sciences clinic in Colorado and closed the lab of another company, Celltex Therapeutics, in Texas.

While patients in dire situations are willing to try the therapy (and pay the hefty costs), there's concern the research doesn't support broad practice just yet.

Running Out Of Options

SammyJo Wilkinson remembers the day 18 years ago when she suddenly couldn't stand. She was a young, ambitious computer programmer, launching an Internet startup.

Her doctor told her it was secondary progressive multiple sclerosis.

Now, at 48, Wilkinson is in a wheelchair. She's tried every available FDA-approved drug and two experimental therapies, including a two-year course of chemotherapy. Nothing worked.

Over time, she started researching adult stem cell replacement, but it was available only abroad. The U.S. opened its doors to the treatment two years ago.

Wilkinson had to see a doctor first, but then she paid Celltex $28,000 for stem cell replacement. In a nutshell, the company promises to remove good, healthy stem cells; store them; make more; and put them back into her body where they can help her heal.

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FDA Challenges Stem Cell Companies As Patients Run Out Of Time

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